K020634 is an FDA 510(k) clearance for the MODIFICATION TO ATRIUM MEDICAL CORPORATION CLEARWAY PTFE BALLOON CATHETER. This device is classified as a Catheter, Embolectomy (Class II - Special Controls, product code DXE).
Submitted by Atrium Medical Corp. (Hudson, US). The FDA issued a Cleared decision on May 8, 2002, 70 days after receiving the submission on February 27, 2002.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.5150.
| 510(k) Number | K020634 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 27, 2002 |
| Decision Date | May 08, 2002 |
| Days to Decision | 70 days |
| Submission Type | Special |
| Review Panel | Cardiovascular (CV) |
| Summary | Statement |
| Product Code | DXE — Catheter, Embolectomy |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.5150 |